MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC COMPACT SPEED REDUCER, 60:1; MOTOR, DRILL, PNEUMATIC

Model Number CSR60

Device Problem Vibration (1674)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2021

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.The actual device was returned for evaluation.The compact speed reducer device was evaluated and the reported condition that the device stopped working when used with the attachment device was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device had vibration.The assignable root cause of this condition was determined to be traced to component failure due to normal wear.Udi: (b)(4).

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure it was observed that the compact speed reducer device stopped working when used with the attachment device.During in-house engineering evaluation it was determined that the compact speed reducer device had vibration.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: COMPACT SPEED REDUCER, 60:1
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: kara ditty-bovard ; 4500 riverside drive; palm beach gardens, FL 33410 ; 6107428552
• MDR Report Key: 12240850
• MDR Text Key: 264052724
• Report Number: 1045834-2021-01304
• Device Sequence Number: 1
• Product Code: HBB
• UDI-Device Identifier: 00845384001782
• UDI-Public: 00845384001782
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K960630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSR60
• Device Catalogue Number: CSR60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Date Manufacturer Received: 07/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1